A RECENT international Phase 3 clinical trial has demonstrated that a combination of toripalimab and bevacizumab significantly improves survival outcomes in patients with previously untreated advanced hepatocellular carcinoma, when compared with the current standard treatment, sorafenib.
Hepatocellular carcinoma remains a leading cause of cancer-related death worldwide, and treatment options remain limited, especially where regulatory, insurance, or cost barriers exist. This trial, known as the HEPATORCH study, sought to address this gap.
Conducted across 57 hospitals in mainland China, Taiwan, and Singapore, the study enrolled 326 eligible patients with unresectable or metastatic liver cancer, randomly assigning them to receive either intravenous toripalimab and bevacizumab every three weeks or oral sorafenib twice daily. The primary outcomes were progression-free survival and overall survival, with safety also carefully assessed.
Results showed that patients receiving the combination therapy experienced a median progression-free survival of 5.8 months, compared with 4.0 months for those treated with sorafenib. More strikingly, the combination extended overall survival to a median of 20.0 months, compared with 14.5 months for sorafenib, with both differences proving statistically significant.
The safety profiles of both treatments were broadly similar, with 63% of patients on the combination therapy experiencing grade 3 or higher adverse events, compared to 61% on sorafenib. Common side effects in the combination group included hypertension, thrombocytopenia, and gastrointestinal bleeding, though the rates of treatment-related fatal events were equally low in both groups.
These findings mark an important step forward in the treatment of advanced liver cancer, offering a more effective therapeutic option with manageable side effects. As a result, the combination of toripalimab and bevacizumab has received approval for clinical use in China, potentially paving the way for wider international adoption.
Reference
Shi Y et al. Toripalimab plus bevacizumab versus sorafenib as first-line treatment for advanced hepatocellular carcinoma (HEPATORCH): a randomised, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2025;10(7):658-70.
